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. Author manuscript; available in PMC: 2014 May 2.
Published in final edited form as: Cochrane Database Syst Rev. 2010 Jan 20;(1):CD007482. doi: 10.1002/14651858.CD007482.pub2
Methods Randomized, placebo-controlled trial; 2 parallel groups.
Unit of randomization: individual.

Participants Dates of data collection: not reported.
Setting: Central Baptist Hospital, Lexington, Kentucky, US.
Inclusion criteria: women undergoing primary, non-elective CS (while it appears most women were in labor and/or had ruptured membranes it is unclear whether all patients fulfilled our criteria for non-elective)
Exclusion: antibiotic use within 7 days, penicillin or cephalosporin allergy

Interventions Cefamandole 500 mg IV immediately after the cord was clamped, again in the recovery room and two more doses 6 hours apart (N = 43) vs identical-appearing placebo (N = 47)

Outcomes Infectious morbidity (fever > 100.3°F twice 6 hours apart after first 24 hours); endomy-ometritis (fever, uterine tenderness, and positive culture from endometrium); wound infection, UTI; maternal duration of stay (treatment 5.1 days vs placebo 5.4; not significant, no variance given)

Notes There was 1 episode of bacteremia in the control group.
Class of antibiotic: second generation cephalosporin.
Subgroups:
  • type CS unclear;

  • after cord clamping.


Risk of bias

Item Authors’ judgement Description

Adequate sequence generation? Unclear Randomized. No further information.

Allocation concealment? Yes “according to pre-numbered envelopes maintained in the central pharmacy.”

Blinding? Yes Described as “double-blind”.
All outcomes Placebo-controlled: “identical appearing, equal volume solution”

Incomplete outcome data addressed? Yes No loss to follow up.
All outcomes No participant excluded.
ITT analysis.

Free of selective reporting? Unclear Insufficient information to judge.

Free of other bias? Unclear The 2 groups were comparable regarding age, race, parity, weight, type of anesthesia, operating time or pre-operative hematocrit. There was insufficient other information which to judge

Overall low risk of bias? Unclear Mostly unclear.
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